vidutolimod (CMP-001) / Kuros, Xoma, Regeneron - LARVOL DELTA

A Phase 2, Open-Label Study of Intratumoral Vidutolimod in Combination With Intravenous Pembrolizumab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (COSM 2025) - P2 | "Vidutolimod plus pembrolizumab had a generally manageable safety profile and demonstrated durable disease control among responders in PD-1 inhibitor-naive patients with R/M HNSCC."

Clinical • Combination therapy • Metastases • P2 data • Constipation • Endocrine Disorders • Fatigue • Gastroenterology • Gastrointestinal Disorder • Head and Neck Cancer • Hypotension • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

CMP-001 for Relapsed and Refractory Lymphoma (clinicaltrials.gov) - P1/2 | N=14 | Completed | Sponsor: Umar Farooq | Active, not recruiting ➔ Completed | N=39 ➔ 14 | Trial completion date: Apr 2026 ➔ Apr 2025

Enrollment change • Trial completion • Trial completion date • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy of Treatment in Patients With Operable Melanoma (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Biomarker • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

A phase II randomized study of neoadjuvant pembrolizumab (P) alone or in combination with vidutolimod (V) in high-risk resectable melanoma: ECOG-ACRIN EA6194. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT04708418 The abstract will be released to the public on June 3, 2025 at 8:00 AM EDT"

Clinical • Combination therapy • Late-breaking abstract • P2 data • Melanoma • Oncology • Solid Tumor

Regeneron to Highlight Advances at ASCO with Phase 3 Adjuvant Libtayo (cemiplimab) CSCC Updates and Promising Early Blood Cancer Data with Linvoseltamab Combination (GlobeNewswire) - "Eighteen presentations will share the latest insights from ongoing research of approved and investigational treatment regimens across a range of difficult-to-treat cancers including non-melanoma and melanoma skin cancer, lung cancer, lymphoma and multiple myeloma...Notable presentations at ASCO on Regeneron’s oncology pipeline include detailed efficacy and safety findings from the Phase 3 C-POST trial evaluating the adjuvant use of the PD-1 inhibitor Libtayo in post-surgical high-risk cutaneous squamous cell carcinoma (CSCC). The results will be presented in an oral session on Saturday, May 31...Regeneron will debut results from two cohorts of the LINKER-MM2 trial...which will be featured in two rapid oral presentations on Monday, June 2...In addition, the results of a cooperative group study reporting on the primary analysis of a randomized Phase 2 trial of vidutolimod..."

Clinical data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Lymphoma • Melanoma • Multiple Myeloma • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

A Multicentre, Open-Label, Phase 2 Study of Intratumoural Vidutolimod in Combination with Intravenous Nivolumab in Patients with Refractory, Unresectable or Metastatic Melanoma: Clinical and Correlative Results (EADO-WCM 2025) - P2 | "Conclusions Vidu IT + anti–PD-1 therapy had modest antitumour activity in PD-1 blockade−resistant melanoma pts in this study, suggesting a need for predictive biomarkers in future studies. Treatment led to a notable transient increase in IFN⍺ levels and induced type I/II interferon signalling, consistent with vidu's proposed mechanism of action."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Melanoma • Oncology • Solid Tumor • CXCL10 • IFNG • IL10 • IL6

A Phase 2, Open-Label Study of Intratumoral Vidutolimod in Combination With Intravenous Pembrolizumab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (AHNS-COSM 2025) - P2 | "Vidutolimod plus pembrolizumab had a generally manageable safety profile and demonstrated durable disease control among responders in PD-1 inhibitor-naive patients with R/M HNSCC."

Clinical • Combination therapy • Metastases • P2 data • Constipation • Endocrine Disorders • Fatigue • Gastroenterology • Gastrointestinal Disorder • Head and Neck Cancer • Hypotension • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

CMP-001 and Pre-operative Stereotactic Body Radiation Therapy (SBRT) in Early Stage Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Centre Hospitalier Universitaire Vaudois | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Sep 2023 ➔ Dec 2025 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy of Treatment in Patients With Operable Melanoma (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Suspended ➔ Active, not recruiting

Biomarker • Enrollment closed • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

CMP-001 for Relapsed and Refractory Lymphoma (clinicaltrials.gov) - P1/2 | N=39 | Active, not recruiting | Sponsor: Umar Farooq | Suspended ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy in Patients With Operable Melanoma (clinicaltrials.gov) - P2 | N=60 | Suspended | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2024 ➔ Jun 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Biomarker • Combination therapy • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

CMP-001 for Relapsed and Refractory Lymphoma (clinicaltrials.gov) - P1/2 | N=39 | Active, not recruiting | Sponsor: Umar Farooq | Trial primary completion date: Apr 2025 ➔ Aug 2024

Trial primary completion date • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Neoadjuvant vidutolimod and nivolumab in high-risk resectable melanoma: A prospective phase II trial. (PubMed, Cancer Cell) - P2 | "Our findings support that combined vidutolimod and nivolumab stimulates a broad anti-tumor immune response and is associated with distinct baseline myeloid gene signature and gut microbiota. ClinicalTrials.gov identifier: NCT03618641."

IO biomarker • Journal • P2 data • Infectious Disease • Melanoma • Oncology • Solid Tumor • CD8

Intratumoral vidutolimod in combination with PD-1 blockade in locoregionally advanced melanoma. (PubMed, Cancer Cell) - "In this issue of Cancer Cell, Davar and colleagues report a promising phase 2 neoadjuvant trial of the TLR9 agonist vidutolimod in combination with nivolumab. Analyses suggest a unique myeloid expression signature is associated with response."

Combination therapy • IO biomarker • Journal • Metastases • Melanoma • Oncology • Solid Tumor

Intratumoral injection of vidutolimod, an immunostimulatory virus-like particle, enhances the number of intratumoral and circulating tumor-specific CD8 T cells (SITC 2024) - "Conclusions Vidutolimod induced a greater influx of OT-1 T cells into the primary tumor and in circulation which supports previous studies that saw an abscopal effect of non-treated tumors. Vidutolimod also increased the number of circulation PD-1+ OT-1 T cells which supports clinical research of anti-PD-1 therapy in combination with vidutolimod Ethics Approval Mouse studies were approved by and performed according to guidelines established by the University of Iowa Institutional Animal Care and Use Committee under an approved IACUC Protocol #3011236."

IO biomarker • Oncology • CD4 • CD8

A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer (clinicaltrials.gov) - P2 | N=77 | Terminated | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Terminated; Sponsor Decision related to study drug supply

Combination therapy • Metastases • Trial termination • Basal Cell Carcinoma • Breast Cancer • Lung Cancer • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Triple Negative Breast Cancer

CMP-001-011: CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma (clinicaltrials.gov) - P2/3 | N=20 | Terminated | Sponsor: Regeneron Pharmaceuticals | Completed ➔ Terminated; Business Decision

Combination therapy • Metastases • Monotherapy • Trial termination • Melanoma • Oncology • Solid Tumor

CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma (clinicaltrials.gov) - P2 | N=44 | Terminated | Sponsor: Regeneron Pharmaceuticals | Completed ➔ Terminated; Business Decision

Combination therapy • Metastases • Trial termination • Melanoma • Oncology • Solid Tumor • BRAF

CMP-001-007: CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=24 | Terminated | Sponsor: Regeneron Pharmaceuticals | Completed ➔ Terminated; Business Decision

Combination therapy • Metastases • Trial termination • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination with Nivolumab Vs. Nivolumab (clinicaltrials.gov) - P2 | N=9 | Completed | Sponsor: Diwakar Davar | Active, not recruiting ➔ Completed | Trial completion date: Jul 2028 ➔ Aug 2024 | Trial primary completion date: Jul 2028 ➔ Aug 2024

Biomarker • Combination therapy • Trial completion • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • CD8

CMP-001-011: CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma (clinicaltrials.gov) - P2/3 | N=20 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Monotherapy • Trial completion • Melanoma • Oncology • Solid Tumor

Vidutolimod (CMP-001) in Combination With Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=10 | Suspended | Sponsor: Emory University | Recruiting ➔ Suspended

Combination therapy • Metastases • Trial suspension • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer (clinicaltrials.gov) - P2 | N=77 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Suspended ➔ Active, not recruiting | N=225 ➔ 77 | Trial completion date: Jul 2027 ➔ Oct 2024 | Trial primary completion date: Jul 2027 ➔ Oct 2024

Combination therapy • Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Breast Cancer • Lung Cancer • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Triple Negative Breast Cancer

A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) (clinicaltrials.gov) - P1/2 | N=409 | Terminated | Sponsor: Pfizer | Phase classification: P1b/2 ➔ P1/2

Combination therapy • Metastases • Phase classification • Bladder Cancer • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • ALK • EGFR • ROS1

PRE-ISPY phase I/Ib oncology platform program (PRE-I-SPY-P1). (ASCO 2024) - P1 | "The current arms under study are PRE1: ALX-148 combined with trastuzumab deruxtecan; PRE2: tucatinib combined with zanidatamab; and PRE3: vidutolimod combined with cemiplimab. Once safety is established, promising regimens can be rapidly transitioned to I-SPY 2. 2 or other phase 2/3 trials. The first patient was enrolled on 2/1/2023."

P1 data • Breast Cancer • Oncology • Solid Tumor